tempus fugit

An investigation in Sweden into a surgeon who is a pioneer in the field of regenerative medicine has found that he committed scientific misconduct by omitting or falsifying information about the conditions of three patients in medical journals.

Dr. Bengt Gerdin, the independent investigator who looked into accusations against the surgeon, Dr. Paolo Macchiarini, said that in several journal papers, including one in The Lancet in 2011, Dr. Macchiarini had “omitted some data and also fabricated or falsified some data regarding the postoperative state of patients” on whom he had performed experimental groundbreaking operations.

The substance of the accusation was that the surgeon had failed to do followup on several patients into whom he had transplanted prosthetic tracheas of plastic treated with stem cells and regeneration drugs. At the same time, he had reported the followup examinations as if he had really performed them. Two of the patients have died, and the third has been stuck in intensive care for almost three years.

The investigation started last fall after four doctors who treated the patients complained that their conditions had never been as good as represented in the papers published about them. Each patient had suffered a severely damaged trachea which, in an experimental operation, Dr. Macchiarini replaced with a plastic trachea implanted with stem cells. The trachea was treated with drugs that promoted regrowth, and, it was hoped, eventually a new trachea.

There have been both tremendous interest and numerous attempts recently to create new organs, to take the place of damaged ones, with stem cells in a plastic scaffolding that supports regrowth and eventual replacement. Animal experiments have so far been very encouraging. The results of Dr. Macchiarini’s surgeries were the subject of several scientific articles, including a positive report in The Lancet in 2011.

There are also complaints that Dr. Macchiarini failed to obtain adequate informed consent from the involved patients for the operations, and that there had not been appropriate ethical review of the procedures. These accusations will be taken up at another level, according to Dr. Gerdin.

There has been some delay because the report by Dr. Gerdin was published only in Swedish, based on the work that Dr. Macchiarini had done at the Karolinska Institute in Stockholm. Some principals have delayed their response until the report is translated into English. The accused doctor has denied all the allegations and blamed other doctors for the problems.